Mark Kramer joined NDA Partners in 2013. He is a former regulatory affairs executive with the medical device division of GE Healthcare. Prior to that,
he worked for the US Food & Drug Administration (FDA) where he established and directed the Office of Combination Products. Mr. Kramer also directed the
FDA’s Product Jurisdiction Program, which was established to ensure prompt assignment of drug-device, drug-biologic, and device-biologic combination products
to agency Centers, and determine regulatory identity of drugs, devices and biological products for which jurisdiction is unclear or in dispute.

Before heading the Office of Combination Products, Mr. Kramer was Chief of FDA’s Anesthesiology and Defibrillator Devices Branch, Chief of the Urology and
Lithotripsy Devices Branch, Acting Associate Director for Plastic Surgery and Dental Devices, and a lead reviewer for pacing and electrophysiology devices.
Prior to joining FDA, Mr. Kramer worked in product development in the medical device industry.